Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GammaPod - Treatment Planning System-a component of the GammaPod Irradiation Recalled by Xcision Medical Systems, LLC Due to Wrong structures imported into the GammaPod Treatment Planning...

Date: November 30, 2023
Company: Xcision Medical Systems, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Xcision Medical Systems, LLC directly.

Affected Products

GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.

Quantity: 4 units

Why Was This Recalled?

Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Xcision Medical Systems, LLC

Xcision Medical Systems, LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report